Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
NCT ID: NCT04678167
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
51 participants
INTERVENTIONAL
2021-03-10
2027-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
After examination by the ENT specialist (otorhinolaryngologist) who will diagnose vestibular neuritis, the patient will be randomized into one of three groups. The clinical follow-up will be performed by another practitioner, who will not know in which arm the patient is included (the patient will come to the consultation without his glasses). Only the practitioner who realized the randomization and the patient will have information about the arm in which they are located.
Study Groups
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Boarding ring glasses
Realization of the following examinations WITH Boarding ring glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS
Caloric test
Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
Measurement of the speed of Nystagmus
A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
Angle of deviation at Fukuda
The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
Alexander's degree of nystagmus
there are 3 degrees:
* Degree I: nystagmus that exists only when the eyes are turned to the right.
* Degree II: also exists when the eyes are to the right or to the front.
* Degree Ill: exists when the eyes are on the right, front, or left
EHTEV questionnaire
Handicap Scale for Balance Disorders and Vertigo
EEV questionnaire
European Vertigo Assessment Questionnaire
anxiety VAS
visual analog scale of anxiety
Placebo glasses
Realization of the following examinations WITH Placebo glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS
Caloric test
Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
Measurement of the speed of Nystagmus
A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
Angle of deviation at Fukuda
The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
Alexander's degree of nystagmus
there are 3 degrees:
* Degree I: nystagmus that exists only when the eyes are turned to the right.
* Degree II: also exists when the eyes are to the right or to the front.
* Degree Ill: exists when the eyes are on the right, front, or left
EHTEV questionnaire
Handicap Scale for Balance Disorders and Vertigo
EEV questionnaire
European Vertigo Assessment Questionnaire
anxiety VAS
visual analog scale of anxiety
No glasses
Realization of the following examinations WITHOUT glasses :
* caloric tests,
* measurement of the speed of Nystagmus,
* angle of deviation in Fukuda,
* Alexander's degree of nystagmus,
* EHTEV and EEV questionnaires,
* anxiety VAS
Caloric test
Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
Measurement of the speed of Nystagmus
A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
Angle of deviation at Fukuda
The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
Alexander's degree of nystagmus
there are 3 degrees:
* Degree I: nystagmus that exists only when the eyes are turned to the right.
* Degree II: also exists when the eyes are to the right or to the front.
* Degree Ill: exists when the eyes are on the right, front, or left
EHTEV questionnaire
Handicap Scale for Balance Disorders and Vertigo
EEV questionnaire
European Vertigo Assessment Questionnaire
anxiety VAS
visual analog scale of anxiety
Interventions
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Caloric test
Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
Measurement of the speed of Nystagmus
A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
Angle of deviation at Fukuda
The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
Alexander's degree of nystagmus
there are 3 degrees:
* Degree I: nystagmus that exists only when the eyes are turned to the right.
* Degree II: also exists when the eyes are to the right or to the front.
* Degree Ill: exists when the eyes are on the right, front, or left
EHTEV questionnaire
Handicap Scale for Balance Disorders and Vertigo
EEV questionnaire
European Vertigo Assessment Questionnaire
anxiety VAS
visual analog scale of anxiety
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea
* patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear
* patient with a postural deviation towards the affected ear;
* vestibular hyporeflexia measured at the caloric tests greater than 25%
* patient who has given free, enlighten and written consent
Exclusion Criteria
* patient with associated hearing loss or tinnitus
* patient with an motor ocular abnormality of central origin
* patient refusal or inability to consent
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Jean-Christophe LECLERE, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Locations
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CHU de Brest
Brest, , France
CH Pays de Morlaix
Morlaix, , France
CH de Cornouaille Quimper
Quimper, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC20.0040
Identifier Type: -
Identifier Source: org_study_id
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